PleurX 50-9050Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403075964), received between Oct 22, 2021 and Sep 7, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2023Migration; Migration

  30/08/2023 - RESPONSE - THE LOT NUMBER 0001419865 GIVEN CORRESPONDS TO THE MATERIAL 50-9050 AND NOT 50-7050. CAN YOU PLEASE CONFIRM IF THIS IS CORRECT? - YES THIS IS CORRECT, IT WAS A MISTAKE BY MYSELF - WAS THE CUFF LOOSE? - NOT KNOWN - WAS THE CUFF VISIBLE OUTSIDE PATIENT BODY? - YES - WAS THE CUFF DISCONNECTED FROM THE CATHETER? - NOT KNOWN - WHAT WAS THE IMPACT TO THE PATIENT? - LEAKY CATHETER EXIT POINT - WAS THERE INFECTION AT CATHETER SITE? - NOT KNOWN - WAS THERE LEAKAGE? - NOT KNOWN. DESCRIPTION OF THE PROBLEM (WHAT / WHY) - CUFF LOOKS OUT. HOW OFTEN DID THE DEFECT OCCUR - ONCE. MEDICAL INTERVENTION (OTHER THAN FIRST AID) - NOT REQUIRED. NEEDLE STICK/PROBE STICK - NOT REQUIRED. OTHER MEASURES TAKEN - NO SAFETY PROBLEM - NO PROBLEM SOLVED - YES HOW WAS THE PROBLEM RESOLVED / ADDITIONAL INFORMATION - THE PHYSICIAN WAS AT THE FAMILY'S HOME BECAUSE MRS. (B)(6) CURRENT HEALTH CONDITION DOES NOT ALLOW HER TO GO TO THE CLINIC. THE POLYESTER CUFF CONTINUES TO PEEK OUT. THIS IS WHAT MRS. (B)(6) WANTED BECAUSE OTHERWISE SHE WOULD BE IN TOO MUCH PAIN. HOWEVER, THE INCISION ON THE CATHETER WAS CLOSED AGAIN SO THAT NO MORE EFFUSION CAN FLOW OUT. PHOTO / SAMPLE AVAILABLE - NO SAFETY VAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698867 ↗
• MalfunctionFeb 23, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AIR AND FLUID HAVE BEEN LEAKING BOTH IN AND OUT OF THE CONNECTION HUB WHILE DRAINING. FROM CUSTOMER'S REPORT: FLUID LEAK OUT OF CONNECTING TUBING LUER END - ALSO AIR LEAKED INTO TUBES - BUBBLES NOTED IN TUBING OF FLUID. THE LUER END WAS CONNECTED TO 3-WAY TAP TO DRAIN FLUID PRIOR TO CAPPING TUBING. DURING DRAINAGE LEAKING NOTED. MULTIPLE 3-WAY TAPS AND BUNGS ASEPTICALLY CHANGES TO ATTEMPT TO RESOLVE LEAK. VISUALLY COULD BE SEEN FLUID LEAKING FROM THE LUER/THREAD OF CONNECTING TUBING AND AIR ENTRY AT THAT SITE. NO ADVERSE PATIENT OUTCOME. PHOTO REVIEW BY RCC - BUBBLES NOTED IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433610 ↗
• MalfunctionAug 31, 2022Leak/Splash; Leak/Splash

  VALVE WAS LEAKING. PATIENT RECEIVED FREE REPLACEMENTS. VALVE WAS CHANGED. SAFETY CLAMP WAS USED. MANIPULATION. WAS THERE ANY DAMAGE NOTICED ON CATHETER VALVE? UNKNOWN. WAS THE VALVE CRACKED OR BROKEN? MANIPULATED. WHERE IS THE CATHETER LOCATED? ABDOMEN OR CHEST / ABDOMEN. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? A SAMPLE IS AVAILABLE. DOES REPLACING THE VALVE FIXED THE PROBLEM? YES. DID THE PATIENT REQUIRE ADDITIONAL DIAGNOSTICS OTHER THAN THE VALVE REPLACEMENT TO BE ABLE TO DRAIN. UNKNOWN. HOW LONG HAS THE CATHETER BEEN IN PLACE? (B)(6) 2022. WHAT WAS THE IMPACT TO THE PATIENT? NO IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327165 ↗
• MalfunctionJun 30, 2022Complete Blockage; Complete Blockage

  DR. (B)(6) FROM (B)(6) HOSPITAL HAS INFORMED THAT THE CATHETER DID NOT TRACK AND WAS FOUND FAULTY. THE DEFECT WAS WITH THE CATHETER SINCE IT WAS BLOCKED AND WAS FOUND FAULTY FOR THE PASSAGE OF FLUID. THE CATHETER WAS FOR THE CHEST. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14876469 ↗
• MalfunctionDec 22, 2021Complete Blockage; Complete Blockage

  CATHETER NOT DRAINING. AS YOU STATED BY DR (B)(6) PATIENT HAS A PLEURX PERITONEAL DRAIN INSITU. SEEMED TO HAVE BLOCKAGE LAST WEEK WHICH YOU WERE ABLE TO CLEAR USED THE PLEURX ACCESS KIT. NOW CATHETER NOT DRAINING. IMAGING SHOWS CATHETER IN CORRECT PLACE AND NOT LOCULATIONS. HAVE PLACED THESE CATHETERS PREVIOUSLY AND HAD NO ISSUE. WILL EITHER JUST REMOVE OR REPLACE CATHETER DEPENDING OF ATTENDING PHYSICIANS DECISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13059945 ↗
• MalfunctionNov 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  I WANT TO LET YOU KNOW ABOUT A LEAKING VALVE. UNFORTUNATELY, NO FURTHER DATA ARE CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12750735 ↗
• MalfunctionOct 22, 2021Leak/Splash; Leak/Splash

  I WOULD LIKE TO REPORT A MATERIAL SAFETY EVENT THAT OCCURRED AT THE (B)(6) HOSPITAL ON (B)(6) 2021. IT CONCERNS THE PLEURX MINI KIT PERITONEAL CATHETER, REFERENCE (B)(4) AND LOT NUMBER 0001372185. DURING AN OPERATION, THERE WAS A LEAK AT THE CHAMBER (RESERVOIR)-TUBING JUNCTION. THE DEVICE WAS CHANGED DURING THE INTERVENTION. THERE WERE NO CONSEQUENCES FOR THE PATIENT. LOSS OF 2 MINUTES DURING THE PROCEDURE. UNFORTUNATELY, THE MEDICAL DEVICE WAS NOT KEPT FOR EXPERTISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12685501 ↗